Product Description Karsil. Dosage form Coated tablets. Basic physical and chemical properties: coated tablets, regular round shape, brown color, odorless. Dosage 22.5 mg, per pack: 80 pcs. Active ingredient: dry extract of milk thistle fruits; 1 coated tablet contains dry extract of milk thistle fruit (Silybi mariani fructus extractum siccum) (35-50:1) (extractant: methanol ≥ 99.0%) – 40.9-56.3 mg, which is equivalent to 22, 5 mg silymarin; excipients: lactose monohydrate, wheat starch, povidone K 25, microcrystalline cellulose, magnesium stearate, talc, mannitol (E 421), crospovidone, polysorbate 80, sodium bicarbonate; shell: cellulose acetyl phthalate, diethyl phthalate, sucrose, acacia, gelatin, talc, titanium dioxide (E 171), macrogol 6000, Opalux AS 26586 brown sucrose, red iron oxide (E 172), black iron oxide (E 172), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), glycerin. Pharmacotherapeutic group Drugs used in liver diseases, lipotropic substances. Hepatoprotective drugs. ATX code A05B A03. Pharmacological properties Pharmacodynamics. Silymarin is a herbal active component of the drug Karsil®, obtained from extracts of the fruits of the milk thistle plant (Silybum marianum). The drug has a hepatoprotective and antioxidant effect. Karsil® inhibits the penetration of toxins into the liver cells (shown on the poisons of the pale toadstool), and also causes physico-chemical stabilization of the cell membrane of hepatocytes, limits or prevents the loss of soluble components (including transaminases) of liver cells. The antioxidant effect of Karsil® is due to the interaction of silibinin with free radicals in the liver and their transformation into less toxic compounds. Thus, the process of lipid peroxidation is interrupted and no further destruction of cellular structures occurs; toxins are neutralized physiologically. Silymarin stimulates the synthesis of proteins (structural and functional) and phospholipids in damaged liver cells (normalizing lipid metabolism), stabilizes their cell membranes, binds free radicals (antioxidant action), thus protecting liver cells from harmful effects and promotes their regeneration. The clinical effect of the drug Karsil® is manifested in the improvement of the general condition of patients with liver diseases, the reduction of subjective complaints (such as weakness, a feeling of heaviness in the right hypochondrium, loss of appetite, itching, vomiting). Laboratory indicators improve: the activity of transaminases, gamma-glutamyl transferase, alkaline phosphatase and the level of bilirubin in the blood plasma decrease. Long-term use of Karsil® significantly increases the survival rate of patients suffering from liver cirrhosis. Pharmacokinetics. After oral administration, silymarin is slowly and incompletely absorbed from the gastrointestinal tract. It undergoes enterohepatic circulation. Does not accumulate in the body. The half-life of silymarin is 6.3 hours. It is excreted mainly with bile in the form of glucuronides and sulfates. clinical characteristics. Indications Liver toxicity: for maintenance treatment in patients with chronic inflammatory liver disease or cirrhosis. Contraindications Hypersensitivity to the active substance or to any of the excipients. Acute poisoning of various etiologies. Interaction with other drugs and other forms of interaction With the simultaneous use of silymarin and oral contraceptives and drugs used in estrogen replacement treatment, treatment with tamoxifen may reduce the effectiveness of the latter. Due to the inhibition of the cytochrome P450 system, silymarin enhances the effect of antiallergic drugs (fexofenadine), anticoagulants (clopidogrel, warfarin). Silymarin may enhance the effects of drugs such as diazepam, alprazolam, ketoconazole, lovastatin, atorvastatin, vinblastine due to its inhibitory effect on the cytochrome P450 system. Herbal products containing silymarin are widely used as hepatoprotectors in oncological practice along with cytostatics. Clinical studies show an insignificant risk of possible pharmacokinetic interactions of silymarin as an inhibitor of the isoenzyme CYP3A4 and UGT1A1 and cytostatics, which are substrates of these enzymes. Application features Treatment with Karsil® in hepatic lesions will be effective when dieting or abstinence, for example, from alcohol. If jaundice develops, it is necessary to consult a doctor to correct therapy. Due to the possible estrogen-like effect of silymarin, it should be used with caution in patients with hormonal disorders (endometriosis, uterine fibroids, breast, ovarian and uterine carcinoma, prostate carcinoma). In such cases, it is necessary to consult the patient with a doctor. The preparation contains wheat starch as an excipient. Wheat starch may contain gluten, but only in small amounts, and is therefore considered safe for patients with celiac disease (gluten enteropathy). The excipients of the drug include lactose monohydrate. Patients with rare hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take the drug. The drug in the composition of the shell contains sucrose. Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency should not take the drug. The tablet shell contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216). They can cause allergic reactions (possibly delayed). Use during pregnancy or lactation There are no data on the safety and efficacy of the drug during pregnancy or lactation, so it should not be prescribed during this period. The ability to influence the reaction rate when driving vehicles or operating other mechanisms Karsil® does not affect the ability to drive vehicles or work with other mechanisms. Patients with vestibular disorders should use the drug with caution when driving vehicles and working with other mechanisms. Dosing and Administration Tablets should be taken orally as a whole, without chewing, with a sufficient amount of liquid. Adults and children over 12 years of age: Karsil® is used orally, in mild and moderate cases – 1-2 tablets 3 times a day. In severe forms of the disease, the dose can be doubled to 2-4 tablets 3 times a day. The course of treatment is determined individually depending on the nature and course of the disease. The average duration of treatment is 3 months. Children. It is not recommended to use the drug in children under 12 years of age. Overdose There are no reports of cases of overdose. In case of accidental ingestion of a high dose, induce vomiting, gastric lavage, take activated charcoal, and, if necessary, apply symptomatic treatment prescribed by a doctor. Side effects The drug is well tolerated. Rarely, in some cases and with individual hypersensitivity, the following side effects can be observed. From the digestive system: diarrhea as a result of increased liver and gallbladder function, nausea, dyspepsia, vomiting, decreased appetite, flatulence, heartburn. From the immune system: allergic reactions (possibly delayed type); hypersensitivity reactions, including skin rashes, itching, anaphylactic shock. On the part of the hearing organs and the labyrinth: strengthening of existing vestibular disorders. On the part of the respiratory system: shortness of breath. From the urinary system: increased diuresis. From the skin and its derivatives: increased alopecia. Side effects are transient and disappear after stopping the drug without taking special measures. Shelf life 3 years. Storage conditionsKeep out of the reach of children. Store in original packaging at a temperature not exceeding 25 °C. Buy Karsil tablets p/o 22.5mg №10×8 Price for Karsil tablets p/o 22.5mg №10×8
INN | SILYMARIN |
---|---|
The code | 129 707 |
Barcode | 3 800 010 643 771 |
Dosage | 22.5 mg |
Active substance | Silymarin |
Manufacturer | Sopharma OJSC, Bulgaria |
Importer | IOOO "Interfarmaks", Republic of Belarus, 223028, Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Zvezdnaya, 19A-5, pom. 5-2 |
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